Brain Death Clinical Trial
Official title:
A Randomized Trial of Mild Hypothermia and Machine Perfusion in Deceased Organ Donors for Protection Against Delayed Graft Function in Kidney Transplant Recipients
NCT number | NCT02525510 |
Other study ID # | 029669 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 26, 2017 |
Est. completion date | June 1, 2022 |
Verified date | June 2022 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To protect kidney function during the transplantation process by comparing mild hypothermia in the deceased organ donor before organs are recovered and pulsatile perfusion of the kidney after recovery and prior to transplantation.
Status | Completed |
Enrollment | 1427 |
Est. completion date | June 1, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - > 18 years of age, - Brain dead organ donor, - Authorization for research Exclusion Criteria: - Donation after Cardiac Death (DCD) Donor - Coagulopathy, Hemodynamic instability, Electrolyte deficiencies, Pre-existing kidney disease (per study protocol) |
Country | Name | City | State |
---|---|---|---|
United States | Southwest Transplant Alliance | Dallas | Texas |
United States | Donor Alliance | Denver | Colorado |
United States | LifeGift | Houston | Texas |
United States | LifeSource | Minneapolis | Minnesota |
United States | Donor Network of Arizona | Phoenix | Arizona |
United States | Pacific Northwest Transplant Bank | Portland | Oregon |
United States | U C San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Oregon Health and Science University |
United States,
Jochmans I, Watson CJ. Taking the Heat Out of Organ Donation. N Engl J Med. 2015 Jul 30;373(5):477-8. doi: 10.1056/NEJMe1507573. — View Citation
Moers C, Smits JM, Maathuis MH, Treckmann J, van Gelder F, Napieralski BP, van Kasterop-Kutz M, van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Paul A, Pirenne J, Ploeg RJ. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2009 Jan 1;360(1):7-19. doi: 10.1056/NEJMoa0802289. — View Citation
Niemann CU, Feiner J, Swain S, Bunting S, Friedman M, Crutchfield M, Broglio K, Hirose R, Roberts JP, Malinoski D. Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function. N Engl J Med. 2015 Jul 30;373(5):405-14. doi: 10.1056/NEJMoa1501969. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delayed Graft Function in Kidney Allografts | The incidence of DGF in kidneys from deceased donors enrolled in this trial, obtained from publically available OPTN data. | 7 days | |
Secondary | Allograft and Recipient survival for all transplanted organs | Allograft and Recipient survival for all transplanted organs from deceased donors enrolled in this trial obtained from publically available OPTN data. | 1 year |
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